ONAPGO
- Product NDC
- 27505-006
- 11-digit product format
- 275050006
- Labeler code
- 27505
- Product ID
- 27505-006_4aa2a34c-370f-9da6-e063-6394a90ac79b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Apomorphine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc
- Application
- NDA214056
- Marketing category
- NDA
- Marketing start
- 2025-02-04
- Substance
- APOMORPHINE HYDROCHLORIDE
- Active strength
- 4.9 mg/mL
- Pharmacologic classes
- Dopamine Agonists [MoA], Dopaminergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ONAPGO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| APOMORPHINE HYDROCHLORIDE | 4.9 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F39049Y068 |
| Rxcui | 2705789, 2705796 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27505-006-01 | ONAPGO | 20 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 20 | | 16 |
| 27505-006-05 | ONAPGO | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27505-006 | ONAPGO (APOMORPHINE HYDROCHLORIDE) INJECTION, SOLUTION [MDD US OPERATIONS, LLC, A SUBSIDIARY OF SUPERNUS PHARMACEUTICALS, INC] | 8 | Current NDC, 2 package rows | 20250328_f3552b6e-5ae7-4993-aa1a-e399c4a7080a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 27505-006-01 | 27505000601 | 20 mL in 1 CARTRIDGE | 20 ml | | | | Historical |
| 27505-006-05 | 27505000605 | 5 CARTRIDGE in 1 CARTON (27505-006-05) / 20 mL in 1 CARTRIDGE (27505-006-01) | 5 cartridge | 2025-02-04 | No | No | Historical |